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Ketoconazole Administration on How It is Affects the Body and Broken Down and How It Acts on the Body When Used with VELCADE - Article


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Clinical Trial: Ketoconazole Administration on How It is Affects the Body and Broken Down and How It Acts on the Body When Used with VELCADE

This study is currently recruiting patients.
Verified by Millennium Pharmaceuticals August 2005

Sponsored by: Millennium Pharmaceuticals
Information provided by: Millennium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00129207

Purpose

The purpose of this study is to investigate how NIZORAL affects the pharmacokinetics (how the study drug is affected by the body and broken down) and pharmacodynamics (how the study drug acts on the body) of the active ingredient in the study drug VELCADE.
Condition Intervention Phase
Advanced Solid Tumors
 Drug: bortezomib
Phase I

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Official Title: Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients with Advanced Solid Tumors

Further Study Details: 

Expected Total Enrollment:  12

Study start: November 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Male and female patients 18 years of age or older, with a diagnosis of advanced solid tumor for which no curative or other treatment of higher priority is available, will be eligible for this study.

Key inclusion criteria include:

Karnofsky Performance Status (KPS) equal to or greater then 70%, normal liver function tests (aspartate transaminase [AST] or alanine transaminase [ALT] equal to or less then 2 x upper limit of normal (ULN), total bilirubin equal to or less then 1.5 x ULN, calculated creatinine clearance equal to or greater then 50 mL/min, and normal serum calcium.

Key exclusion criteria include:

Patients with significant cardiac disease, equal to or greater then Grade 2 neuropathy, active hepatitis, HIV infection, secondary malignancy, or who are transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment will be excluded.

Patients taking concomitant medications having inhibitory or inducing activity for CYP 3A4 will be excluded from enrollment.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00129207

Christine Colby, Pharm D      1-866-835-2233    christine.colby@mpi.com

Pennsylvania
      Medical Center, UPMC Cancer Pavilion, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

More Information

Study ID Numbers:  M34103-059; 56,515
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129207
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23

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